BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS INVERSE HUMERAL PE-INLAY 40-3

    MDR report key: 3060206 · Received April 11, 2013

    Report

    Report Number
    9613350-2013-01486
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    October 6, 2010
    Report Date
    March 26, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO LOOSENING OF THE GLENOID IMPLANT, THE PROSTHESIS WAS REVISED. PATIENT PART OF SHOULDER REGISTRY - STUDY (B)(6). THE COMPLICATION WAS REPORTED BY THE STUDY SITE AS NOT BEING RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154879 AS INVERSE HUMERAL PE-INLAY 40-3 NONE HSD ZIMMER GMBH 2488573

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R